linvoseltamab
Trade name: Lynozyfic
mAbapprovedMulti-specificOrphan Drug FDA
Approved
Jul 2, 2025
Clinical trial activity
18 trials · 9 clinical orgs · 1 marketing orgs
Phase 1
8
Phase 2
15
Phase 3
3
Phase 4
0
Earliest trial started Jan 23, 2019 (NCT03761108)
Timeline
Indications
Approved for
Mechanism of action
TNFRSF17 adcc
- T-cell surface glycoprotein CD3 epsilon chainImmunity, passive
CD3E immunity, passive
Approval history
- approvedPriority reviewJul 2, 2025
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- Yes
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL5095373 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07181941 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2026 | Regeneron, University of Washington |
| NCT07222761 | Phase 3 | Jan 29, 2026 | Regeneron |
| NCT06910124 | Phase 2 | Dec 1, 2025 | Regeneron, University of Miami |
| NCT07009899 | Phase 2 | Dec 1, 2025 | Medical College of Wisconsin |
| NCT06932562 | Phase 3 | Oct 31, 2025 | Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista, Erasmus University Rotterdam, European Myeloma Network, Regeneron |
| NCT07053436 | Phase 2 | Oct 1, 2025 | Multiple Myeloma Research Consortium, Multiple Myeloma Research Foundation |
| NCT06669247 | Phase 1/Phase 2 (Phase 2) | Dec 20, 2024 | Regeneron |
| NCT06376526 | Phase 2 | Aug 21, 2024 | Regeneron, University of Miami |
| NCT06292780 | Phase 1/Phase 2 (Phase 2) | Aug 7, 2024 | Regeneron |
| NCT06369467 | Phase 1 | May 17, 2024 | Regeneron |
| NCT06140524 | Phase 2 | Apr 30, 2024 | Regeneron |
| NCT05828511 | Phase 1/Phase 2 (Phase 2) | Jan 12, 2024 | Regeneron |
| NCT05955508 | Phase 2 | Dec 14, 2023 | Regeneron |
| NCT05730036 | Phase 3 | Sep 18, 2023 | Regeneron |
| NCT05137054 | Phase 1 | Mar 28, 2022 | Regeneron |
| NCT05092347 | Phase 1/Phase 2 (Phase 2) | Jan 11, 2022 | Regeneron |
| NCT03761108 | Phase 1/Phase 2 (Phase 2) | Jan 23, 2019 | Regeneron |
| NCT05164250 | N/A | — | Regeneron |
Showing 18 of 18 trials
Page 1 / 1
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Regeneron | For profit | 16 | 12 | 4 | 2019 |
| University of Miami | Academic/Hospital | 2 | 2 | 1 | 2024 |
| Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Erasmus University Rotterdam | Academic/Hospital | 1 | 0 | 1 | 2025 |
| European Myeloma Network | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Medical College of Wisconsin | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Multiple Myeloma Research Consortium | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Multiple Myeloma Research Foundation | Academic/Hospital | 1 | 0 | 1 | 2025 |
| University of Washington | Academic/Hospital | 1 | 1 | 1 | 2026 |
9 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Regeneron | For profit | MKTG | Jul 2, 2025 |